Cleared Traditional

K941037 - BNOS MICRO VENT

K941037 is the FDA 510(k) clearance for BNOS MICRO VENT by Reeves Manufactoring. It is a Class 2 Anesthesiology device (product code BTM) cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K941037 · Reeves Manufactoring · Anesthesiology device
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Aug 1994
Decision
169d
Days
Class 2
Risk

K941037 is an FDA 510(k) clearance for the BNOS MICRO VENT, MODEL AC AND MODEL AO. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Reeves Manufactoring (Frederick, US). The FDA issued a Cleared decision on August 18, 1994 after a review of 169 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5915 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Reeves Manufactoring devices

Submission Details

510(k) Number K941037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1994
Decision Date August 18, 1994
Days to Decision 169 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 140d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTM Ventilator, Emergency, Manual (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5915
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BTM Ventilator, Emergency, Manual (resuscitator)

All 33
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K941037.
OHMEDA INFANT RESUSCITATION SYSTEM
K971243 · Ohmeda Medical · Dec 1997
RESPIRONICS BAGEASY ENCOR ADULT SEMI-REUSABLE
K934699 · Respironics, Inc. · Jan 1995
PURITAN-BENNETT DISPOSABLE MANUAL RESUSCITATOR (DMR)
K944347 · Puritan Bennett Corp. · Dec 1994
BAGEASY(R) III CHILD/INFANT DISPOS MAN RESUSCITATORS
K940581 · Respironics, Inc. · May 1994
BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR
K934310 · Respironics, Inc. · Dec 1993
MODIFICATION PURITAN-BENNETT INFANT PM2
K922004 · Puritan Bennett Corp. · May 1992